U.S. patent application number 09/782654 was filed with the patent office on 2002-08-15 for vacuum skin sample collection apparatus.
Invention is credited to Hall, Stanley.
Application Number | 20020111563 09/782654 |
Document ID | / |
Family ID | 25126748 |
Filed Date | 2002-08-15 |
United States Patent
Application |
20020111563 |
Kind Code |
A1 |
Hall, Stanley |
August 15, 2002 |
Vacuum skin sample collection apparatus
Abstract
Apparatus for collection of a skin sample from a patient that
includes an elongated generally tubular barrel having first and
second axial extremities and having an interior chamber in
communication with the first axial extremity. The first axial
extremity of the generally tubular barrel has a sharp edge. The
apparatus further includes apparatus for connecting the interior
chamber to an associated vacuum source and apparatus for directing
a vacuum from the associated vacuum source to the sharp edge. Some
forms of the invention include a stop member disposed within the
barrel for limiting the thickness of the skin sample. The stop
member may be a perforate body. The apparatus may further include
apparatus for securing the stop member in a plurality of discrete
axial positions whereby the thickness of the skin sample may be
defined before the collection process starts. The apparatus may
include a visual display apparatus indicating the thickness of the
skin sample for each of a plurality of axial positions of the stop
member within the barrel.
Inventors: |
Hall, Stanley; (Ripon,
CA) |
Correspondence
Address: |
ROBERT S. SMITH
LAW OFFICES OF ROBERT S. SMITH
SUITE 306
1131-O TOLLAND TURNPIKE
MANCHESTER
CT
06040
US
|
Family ID: |
25126748 |
Appl. No.: |
09/782654 |
Filed: |
February 13, 2001 |
Current U.S.
Class: |
600/566 |
Current CPC
Class: |
A61B 10/0266 20130101;
A61B 2090/036 20160201; A61B 10/0283 20130101 |
Class at
Publication: |
600/566 |
International
Class: |
A61B 010/00 |
Claims
I claim:
1. Apparatus for collection of a skin sample which comprises: an
elongated generally tubular barrel having first and second axial
extremities and having an interior chamber in communication with
said first axial extremity, said first axial extremity of said
generally tubular barrel having a sharp edge; and means for
connecting said interior chamber to an associated vacuum source and
means for directing a vacuum from the associated vacuum source to
said sharp edge.
2. The apparatus in accordance with claim 1 further including a
stop member disposed within said barrel for limiting the thickness
of the skin sample.
3. The apparatus in accordance with claim 2 wherein said stop
member is a perforate body.
4. The apparatus in accordance with claim 3 further including means
for securing said stop member in a plurality of discrete axial
positions whereby the thickness of the skin sample may be defined
before the collection process starts.
5. The apparatus in accordance with claim 4 wherein said apparatus
includes a visual display means indicating the thickness of the
skin sample for each of a plurality of axial positions of said stop
member within said barrel.
6. The apparatus in accordance with claim 5 further including a
regulator for regulating the vacuum proximate to said sharp
edge.
7. The apparatus in accordance with claim 6 further including a
valve for selectively connecting said interior chamber to ambient
and to selectively reduce the vacuum within said interior
chamber.
8. The apparatus in accordance with claim 7 wherein said cutting
edge is circular.
9. The apparatus in accordance with claim 7 wherein said cutting
edge is oval.
10. The apparatus in accordance with claim 7 wherein said barrel
has a circular cross-section.
Description
BACKGROUND OF THE INVENTION
[0001] The invention relates to medical apparatus and particularly
to apparatus for collecting skin specimens or samples suitable for
performing a biopsy as well as other medical procedures. While the
description herein may refer primarily to apparatus for obtaining a
sample for a biopsy, those skilled in the art will recognize that
it also has application for obtaining other specimens suitable for
other medical testing. In addition the apparatus in accordance with
the present invention is also useful in applications where skin
plug samples are needed. For example, hair plugs may be extracted
with the apparatus in accordance with present invention from a
patient for placement in a different part of the scalp of the donor
or to a different recipient. In some cases the apparatus of the
present invention may be used to extract a skin plug as a prelude
to implanting a hair plug.
[0002] The prior art apparatus employs a skin plug cutter unit that
includes a small diameter tube with a sharpened end. The sharp end
is pushed downward into the skin and twisted. This pushing,
twisting and cutting action helps the cutting process. The end of
the chamber has to be round so that rotation of the tube will cut
the surface of the skin with a minimum of trauma to the specimen
being collected as well as the surrounding tissue. Thereafter the
skin plug produced in this manner is mechanically lifted, cut with
a scalpel or scissors and saved in a vessel with a protective
liquid. The skin plug is then inspected and tested.
[0003] A primary problem with this and other prior art methods is
the damage done to the skin plug during the removal process. The
living cells in the plug are generally crushed, squeezed of fluid,
and otherwise damaged by mechanical extraction with tweezers or a
needle. This makes testing very difficult and leads to test results
that are not reliable. In addition the round skin plug cutout is
slow to heal as a circle has a larger minimum dimension for a given
area, as compared to an oval shape.
SUMMARY OF THE INVENTION
[0004] It is an object of the invention to provide an apparatus to
collect skin plugs for medical procedures and which does not damage
the skin sample.
[0005] Another object invention is to provide apparatus that is
practical and which enables a technician to easily collect a skin
sample including skin plug samples.
[0006] It has now been found that these and other objects of the
invention may be attained in apparatus for collection of a skin
sample that includes an elongated generally tubular barrel having
first and second axial extremities and having an interior chamber
in communication with the first axial extremity. The first axial
extremity of the generally tubular barrel has a sharp edge. The
apparatus further includes means for connecting the interior
chamber to an associated vacuum source and means for directing a
vacuum from the associated vacuum source to the sharp edge.
[0007] Some forms of the invention include a stop member disposed
within the barrel for limiting the thickness of the skin sample.
The stop member may be a perforate body. The apparatus may further
include means for securing the stop member in a plurality of
discrete axial positions whereby the thickness of the skin sample
may be defined before the collection process starts. The apparatus
may include a visual display means indicating the thickness of the
skin sample for each of a plurality of axial positions of the stop
member within the barrel.
[0008] The apparatus may further include a regulator for regulating
the vacuum proximate to the sharp edge. The apparatus may also
further include a valve for selectively connecting the interior
chamber to ambient and to selectively reduce the vacuum within the
interior chamber. The cutting edge may be circular, oval, or
various other shapes.
BRIEF DESCRIPTION OF THE DRAWING
[0009] The invention will be better understood by reference to the
accompanying drawing in which:
[0010] FIG. 1 is an enlarged partially cross-section elevational
schematic view of a preferred form of the invention.
[0011] FIG. 2a is a partial cross-section elevational schematic
view of apparatus similar to that illustrated in FIG. 1 as the
apparatus is first pressed against the skin of a patient as part of
the process of collecting a skin specimen.
[0012] FIG. 2b is a partial cross-section elevational schematic
view of the apparatus illustrated in FIG. 2a as a vacuum is first
applied to the skin of the patient while the apparatus is pressed
against the skin of the patient.
[0013] FIG. 2c is a partial cross-section elevational schematic
view of the apparatus illustrated in FIG. 2a as the apparatus is
pushed further into the skin of the patient concurrently with the
application of a vacuum to the surface of the skin.
[0014] FIG. 2d is a partial cross section elevational schematic
view of the apparatus illustrated in FIG. 2a after the apparatus
has been pushed still further into the surface of the skin of the
patient and the outer surface of the skin is disposed in abutting
relationship with a stop that is adjustable to define the thickness
of the specimen.
[0015] FIG. 2e is a partial cross-section elevational schematic
view of the apparatus illustrated in FIG. 2a after the skin plug or
specimen has been drawn into the barrel of the apparatus until the
specimen reaches the stop that determines the thickness of the
specimen and after the apparatus has been withdrawn from the
surface of the skin of the patient with the aid of a scalpel.
[0016] FIG. 2f is a partial cross-section elevational schematic
view of the apparatus illustrated in FIG. 2a after the apparatus
has been moved away from the surface of the skin of the patient
with the skin sample tissue plug, that has been removed from the
patient's surrounding tissue, is retained within the apparatus.
[0017] FIG. 2g is a partial cross-section elevational schematic of
the apparatus illustrated in FIG. 2a that illustrates the sample
tissue plug being ejected into a sample retention vial.
[0018] FIG. 3 is a partial cross-section elevational schematic of
the apparatus illustrated in FIG. 2a that illustrates view of one
embodiment of the apparatus that includes a tissue or plug stop, an
adjustment that enables the user to predefine a desired specimen or
sample thickness with an indicator to visually display the specimen
thickness.
[0019] FIG. 3a is an elevation view of another similar indicator
used to visually display the specimen thickness.
[0020] FIG. 4 is a schematic view of the apparatus illustrated in
FIG. 1 together with a vacuum connection, control valve, vacuum
gauge, and vacuum regulator.
[0021] FIG. 5 is a partial schematic view of apparatus similar to
the apparatus illustrated in FIG. 1 that has an oval shaped cutting
edge surface that engages the surface of the patients skin to
produce an oval shaped plug.
[0022] FIG. 6 is a partial cross-section schematic view of the
apparatus FIG. 1 that illustrates a screw type adjustment for
actually positioning the skin plunger assembly stop.
[0023] FIGS. 7a, 7b, 7c, 7d, and 7e, are cross-section schematic
views of various forms of a screw type adjustment skin plunger
assembly for the apparatus illustrated in FIG. 1.
[0024] FIG. 8 is a cross-section schematic view of apparatus
similar to the illustrated in FIG. 1 that incorporates a screw type
adjustment skin plunger assembly.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0025] Referring now to FIG. 1 there is shown a vacuum skin sample
collection apparatus 10 that includes a barrel or vacuum chamber
cylinder 11. The lowest (as viewed) axial extremity of the barrel
11 is a sharp cutting edge 12. In the embodiment illustrated in
FIG. 1 the cutting edge 12 is circular although other embodiment
may have other contours. Disposed at the upper (as viewed) axial
extremity of the barrel 11 is a vacuum pressure regulator for
control valve 13. A vacuum release valve 14 extends through the
sidewall of the barrel 11. The vacuum release valve 14 enables the
user to vent the air to ambient and from the barrel 11 to reduce
the vacuum within the barrel 10 to avoid an excess vacuum at the
time of collection of the specimen. In addition the operator of the
apparatus will also use the vacuum release valve 14 to release the
specimen from the vacuum skin sample collection apparatus 10 into a
collection vial.
[0026] Also disposed at the upper axial extremity of the barrel 11
is a vacuum tube connector 15 for connection to a vacuum pump 30
(shown in FIG. 4) that produces the vacuum within the barrel 11
that assists in achieving withdrawal of a skin plug from a patient.
The vacuum skin sample collection apparatus 10 further includes a
cylinder assembly 16 disposed at the lower (as viewed) axial
extremity of the barrel 11. The cylinder assembly 16 has a central
passageway 17 that allows passage of air being withdrawn by a
vacuum pump (shown in FIG. 4) through the vacuum tube connector 15.
An O-ring seal 19 is disposed within the groove 18 proximate to the
upper (as viewed) axial extent of the cylinder assembly 16. The
seal 19 insures that the vacuum drawn by the vacuum pump 30 and
connected to the vacuum tube connector 15 is directed to the
central passageway 17.
[0027] Attached to the lower (as viewed) axial extremity of the
cylinder assembly 16 is a plug stop 21. The plug stop 21 is a
perforate element intended to limit the maximum travel of a skin
plug into the barrel 11 of the vacuum skin collection apparatus 10.
The cylinder assembly 16 is provided with a cylinder stop 22 and is
engaged by an adjustment screw 23 that extends through the wall of
the barrel 11 to abut the cylinder stop 22. More specifically, the
adjustment screw 23 engages the cylinder stop 22 to lock the
cylinder assembly 16 with the associated plug stop 21 in an axial
position with respect to the barrel 11 corresponding to a desired
skin plug thickness. Disposed within the barrel 11 is a spring 24
that biases the axial position of the cylinder assembly 16 with
respect to the axial extent of the barrel 11.
[0028] Further details of the construction of the cylinder assembly
are shown in FIGS. 7a-7d. These views illustrate the connection
between the plug stop 21 and the rest of the cylinder assembly 16.
FIG. 7c illustrates a plurality of recesses along the side of the
cylinder assembly that are dimensioned and configured for receiving
the adjustment screw 23 to lock the cylinder assembly in place.
[0029] Connected to the vacuum tube connector 15 is a vacuum hose
25. As best seen in FIG. 4 a vacuum regulator 26 and a vacuum gauge
are disposed within the vacuum hose 25. The vacuum hose 25 also
connects to a vacuum beaker 27.
[0030] FIGS. 2a-2g illustrate the sequential steps involved in
withdrawing a skin plug from the surrounding skin tissue of the
patient. FIG. 2a shows the apparatus first being pressed against
the skin of a patient as part of the process of collecting specimen
a skin specimen. FIG. 2b illustrates the relationship as a vacuum
is first applied to the skin of the patient while the apparatus is
pressed against the skin of the patient and the cutting edge 12 has
penetrated the epidermis 32. FIG. 2c is a view of apparatus
illustrated in FIG. 2a as the apparatus is pushed further into the
skin of the patient concurrently with the application of a vacuum
to the surface of the skin. More specifically, the cutting edge 12
has passed completely through the epidermis 32 and entered the
dermis 33 in this step. FIG. 2d shows the apparatus after it has
been pushed still further into the surface of the skin of the
patient and the outer surface of the skin is disposed in abutting
relationship with the stop 21 that is adjustable to define the
thickness of the specimen. More specifically, because of the
setting of the plug stop 21 the cutting edge 12 has passed
completely through the epidermis 32, the dermis 33 and part of
subcutaneous fat layer 34. FIG. 2e shows the apparatus and skin
after the skin plug or specimen has been drawn into the barrel of
the apparatus until the specimen reaches the stop that determines
the thickness of the specimen and after the apparatus has been
withdrawn from the surface of the skin of the patient with the aid
of a scalpel. FIG. 2f shows the apparatus and skin after the
apparatus has been moved away from the surface of the skin of the
patient with the skin sample tissue plug. The plug has been removed
from the patient's surrounding tissue and is retained within the
apparatus. FIG. 2g is a schematic of the sample tissue plug being
ejected into a sample retention vial 27 that holds a protective
fluid 28. The project fluid 28 is provided to maintain the
integrity of the specimen.
[0031] This invention utilizes a vacuum to assist in the extraction
of a specimen from the surrounding tissue of the patient. Stated
another way, the apparatus 10 in accordance with the preferred form
of the invention utilizes a vacuum to position a skin plug within a
receiving chamber within the barrel 11. After the vacuum draws the
skin plug into the journal of the vacuum skin sample collection
apparatus 10, the plug is severed from the surrounding tissue by a
scalpel. The skin plug travels up the chamber to a preset stop 21.
The stop 21 is preset to a position corresponding to a specific
plug thickness with the aid of a visual indicator. Thus, the
thickness is predefined by the vacuum skin sample collection
apparatus 10. The More specifically, the cylinder assembly 16 is
movable axially within the barrel 11 to position the stop 21. Thus,
the thickness of the plug is known prior to severing the plug from
the surrounding tissue. The skin test plug is severed with a sharp
scalpel or other cutting blade. The skin plug is then deposited
into a sample vessel 27 containing a storage solution 28. The
vacuum pressure is controlled throughout the procedure to minimize
any damage to the skin plug.
[0032] In some embodiments of the invention of the skin specimen is
a cylindrical plug having a circular cross-section. In other
embodiments of the invention of plug has an oval shaped
cross-section. An oval cross-section is advantageous because the
recess remaining after removal of the plug is much easier to close
and may even be closed with a butterfly bandage, If a suture is
required, a single suture will be effective in many cases. It will
be understood that an opening having an oval shape and having the
same cross-section area as a round plug will be easier to close and
will heal faster.
[0033] The vacuum skin sample collection apparatus in accordance
with the present invention includes a cylindrical or oval cylinder
with an adjustable stop feature. An adjustment screw controls the
stop feature. This allows for presetting the skin plug to any
thickness desired. To minimize the need for twisting and rocking
action of prior art units this invention includes a connection to
the chamber for a vacuum line. A control valve and vacuum regulator
allows for the proper vacuum desired. The regulator allows for
different vacuum settings for different skin types. As the end of
the chamber is lightly placed against the skin a vacuum is produced
within the chamber. The skin within and in contact with the end of
the vacuum skin sample collection apparatus 10 is gently drawn into
the chamber due to the vacuum action. The skin plug travels up the
chamber until it reaches a preset stop. This stop has a small
opening for the evacuated air between the stop and the skin to
travel. As the air is evacuated the skin touches the stop. The
vacuum may be partly reduced at this contact point by means of a
by-pass opening to ambient air to avoid excess vacuum on the skin
plug. The skin plug within the chamber is then lifted to skin
level, severed and deposited in a sample vessel that contains a
protective fluid.
[0034] By providing a vacuum to draw the skin into a chamber the
chamber may be of any desired shape. The ideal skin plug shape is
an oval as this allows for the edges of the skin to come together
by use of tape, avoiding sutures, and reduce the risk of
scaring.
[0035] Advantageously, the vacuum skin sample collection apparatus
in accordance with present invention achieves the collection of
skin plug samples that are of uniform size, shape, thickness and
free of the crushed or squeezed cells as with conventional samples.
The testing laboratory will receive the samples in an ideal
condition to obtain reliable biopsy test results. Advantageously,
the vacuum skin sample collection apparatus enables the collection
of skin samples in a manner that the patient will find to be less
painful. In addition the collection process where the apparatus of
present invention will cause less trauma to the surrounding tissue.
Accordingly, the surrounding tissue will heal faster. Because the
apparatus in accordance with present invention enables collection
of an oval plug, the edges of the skin can drawn together in many
cases with tape. Accordingly, healing occurs more rapidly, the
danger of infection is reduced and the possibility of scarring is
reduced.
[0036] Although the vacuum skin sample collection apparatus has
been shown in forms capable of collecting samples that are circular
as well as samples that are oval, those skills in the art will
recognize that other forms of present invention may have many other
alternative shapes and sizes.
[0037] The vacuum skin sample collection apparatus in accordance
with present invention is preferably manufactured of stainless
steel. Ordinarily the barrel or cylinder of the apparatus is
manufactured from stainless steel cylinder tubing. The complete
apparatus includes an adjustable stop and a vacuum connector as
well as adjustment valves, a regulator and a vacuum gauge are part
of the complete system. The materials used in the construction may
include an FDA approved plastic that can be disposed of after a
single use.
[0038] While the present invention has been described with
reference to the preferred embodiments illustrated in the drawing,
the detailed description thereof is not intended to limit the scope
of the invention as claimed in the appended claims.
* * * * *